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breaking Medical Tech Stock news for
Aethlon Medical, Inc.
(Nasdaq: AEMD), a medical therapeutic company focused on developing products to
treat cancer and life-threatening infectious diseases.
Aethlon Medical, Inc.
(Nasdaq: AEMD), a clinical-stage biotechnology company developing
the investigational Aethlon Hemopurifier®, an extracorporeal
device for oncology and other indications, today announced that the
independent Data Safety Monitoring Board (DSMB) overseeing its
ongoing clinical trial AEMD-2022-06 has completed its scheduled
safety review of the second cohort participant data and recommended
advancing to the third and final cohort. They also stated that
“no safety concerns were noted with Hemopurifier
device/procedure”.
The trial, titled “Safety, Feasibility, and Dose-Finding Study
of Aethlon Hemopurifier in Patients with Solid Tumors Who Have
Stable or Progressive Disease While on a Treatment That Includes
Pembrolizumab or Nivolumab,” is being conducted to assess the
Hemopurifier’s safety, feasibility, and optimal dosing.
The DSMB—comprised of independent medical experts in
nephrology and oncology—reviewed data from participants
enrolled in the second cohort, in which patients received two
Hemopurifier treatments over a one-week period. Based on their
evaluation, the DSMB found no safety concerns and confirmed that the
Hemopurifier continues to demonstrate a favorable safety and
tolerability profile. To date, no serious adverse events (SAEs) or
Dose-Limiting Toxicities (DLTs) related to the Hemopurifier device
or treatment have been reported.
“The DSMB’s continued positive recommendation supports the safety
profile observed to date and allows us to advance into the third
and final cohort of this study,” said Steven LaRosa, M.D,
Chief Medical Officer of Aethlon Medical. “We are encouraged by
the gathering momentum of the trial and having a final data set
and clinical study report to share with potential investors,
partners and regulatory agencies”.
Enrollment for Cohort 3 is now open. In this final cohort,
participants will receive three Hemopurifier treatments over a
one-week period, further evaluating safety, feasibility, and dosing
parameters at the study’s three active clinical sites in
Australia. This trial is designed to enroll approximately 9 to 18
patients with solid tumors who have stable or progressive disease
while receiving treatment that includes Pembrolizumab
(Keytruda®) or Nivolumab (Opdivo®).
The primary endpoint of this trial is the incidence of adverse
events and clinically significant changes in safety laboratory tests
of Hemopurifier-treated patients. In addition to safety monitoring,
the study is designed to examine the number of Hemopurifier
treatments needed to decrease the concentration of extracellular
vesicles (EVs) and if these changes in EV concentrations improve the
body’s own natural ability to attack tumor cells. These
findings are expected to inform the design of a future efficacy and
safety Premarket Approval (PMA) study required by regulatory
authorities.
Aethlon Medical, Inc. remains committed to advancing the
Hemopurifier for use in oncology and will continue to provide
updates as the clinical trial progresses.
About Aethlon Medical, Inc.
Aethlon Medical, Inc. (Nasdaq: AEMD) is a clinical-stage medical
device company headquartered in San Diego, California. Aethlon is
advancing the Hemopurifier, to address unmet needs in oncology and
infectious disease, using a novel platform designed to selectively
remove circulation pathogenic targets from biologic fluids.
For more information, visit
www.AethlonMedical.com
and follow the Company on LinkedIn.
About Hemopurifier®
The Aethlon Hemopurifier is an investigational medical device designed
to remove enveloped viruses and tumor-derived EVs from circulation. It
is used extracorporeally with a blood pump and combines plasma
separation, size exclusion, and affinity binding using a plant lectin
resin that targets mannose-rich surfaces found on EVs and viruses. EVs
released by solid tumors are believed to play a role in metastasis and
the resistance to immunotherapies and chemotherapy. Removal of
enveloped viruses and extracellular vesicles has been demonstrated in
both vitro studies and human subjects.
The Hemopurifier holds a U.S. Food and Drug Breakthrough Device for:
-
The treatment of individuals with advanced or metastatic cancer
unresponsive to or intolerant of standard-of-care therapy; and -
The treatment of life-threatening viruses not addressed with
approved therapies.
The Hemopurifier is being developed under an open Investigational
Device Exemption (IDE) for both indications.
Additional information can be found at
www.AethlonMedical.com.
Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E
of the Securities Exchange Act of 1934 that involve risks and
uncertainties. Statements containing words such as “may,” “believe,”
“anticipate,” “expect,” “intend,” “plan,” “project,” “will,”
“projections,” “estimate,” “potentially” or similar expressions
constitute forward-looking statements. Forward-looking statements in
this press release include but are not limited to statements
regarding advancement and completion of the Company’s clinical
trial; patient enrollment and timing; the safety, tolerability and
dosing of the Hemopurifier; the potential biological or clinical
effects of the Hemopurifier; the ability of the study to inform
future trials; and the Company’s development plans, regulatory
pathway and potential applications of the Hemopurifier. Such
forward-looking statements are subject to significant risks and
uncertainties and actual results may differ materially from the
results anticipated in the forward-looking statements. These
forward-looking statements are based upon Aethlon’s current
expectations and involve assumptions that may never materialize or
may prove to be incorrect. Factors that may contribute to such include, without limitation, the number of patients who receive pembrolizumab or nivolumab that will have
lasting clinical responses to these agents; device deficiencies or immediate complications;the possibility of novel treatment strategies; how the Hemopurifier may reduce tumor-derived extracellular
vesicles and enhance T cell activity against tumors; the efficacy of
continued clinical trials; development under IDE for indications;
and/or the number of patients enrolled in each cohort. The foregoing
list of risks and uncertainties is illustrative but is not
exhaustive. Additional factors that could cause results to differ
materially from those anticipated in forward-looking statements can
be found under the caption “Risk Factors” in the Company’s Annual
Report on Form 10-K for the year ended March 31, 2024, and in the
Company’s other filings with the Securities and Exchange Commission,
including its quarterly Reports on Form 10-Q. All forward-looking
statements contained in this press release speak only as of the date
on which they were made. Except as may be required by law, the
Company does not intend, nor does it undertake any duty, to update
this information to reflect future events or circumstances. The findings described herein are preliminary in nature, have not
been peer-reviewed, and may not be replicated in subsequent studies
or clinical trials.
Company Contact:
Jim Frakes
Chief Executive
Officer and Chief Financial Officer
Aethlon Medical, Inc.
Jfrakes@aethlonmedical.com
Investor Contact:
Susan Noonan
S.A. Noonan
Communications, LLC
susan@sanoonan.com
Aethlon Medical Inc. (Nasdaq:AEMD) is a featured biotech stock on
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a paid featured medical tech stock on
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